UMIN-CTR Clinical Trial

Basic information
Public title	Observational study on the effectiveness and validity of treatment for upper gastrointestinal diseases
Acronym	Observational study on the effectiveness and validity of treatment for upper gastrointestinal diseases
Scientific Title	Observational study on the effectiveness and validity of treatment for upper gastrointestinal diseases
Scientific Title:Acronym	Observational study on the effectiveness and validity of treatment for upper gastrointestinal diseases
Region	Japan

Condition
Condition	upper gastrointestinal diseases
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the background, surgical outcome, and postoperative corase of patients who had treated for upper gastrointestinal (esophagus, stomach,and duodenum) disease in our departoment. In addition, we aim to improve our treatment by verifying the validity and effectiveness of past treatment methods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint is related to the validity and prognosis of our treatment, but the specific items are diverse.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients treated at Fujita Health University (department of surgery)
Key exclusion criteria	none
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Uyama
Organization	Fujita Health University
Division name	Surgery
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192 Japan.
TEL	+81-562-93-9254
Email	iuyama@mac.com

Public contact
Name of contact person	1st name Kenji Middle name Last name Kikuchi
Organization	Fujita Health University
Division name	Surgery
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192 Japan
TEL	+81-562-93-9254
Homepage URL
Email	kikuken0414@gmail.com

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fujita Health University Institutional Review Board
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192 Japan
Tel	0562-93-2865
Email	f-irb@fujita-hu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 12 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 17 Day
Date of IRB	2019 Year 04 Month 17 Day
Anticipated trial start date	2019 Year 04 Month 17 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

A retrospective observational study will be conducted for patients with upper gastrointestinal diseases treated at Fujita Health University (department of surgery) since 1997. We will collect the date of patients backgrounds,treatments, surgical outcome including surgical procedures and postoperative coarse. After that, we evaluate their impact on prognosis and the validity of our treatment. Specifically, their medical records, blood test, image, pathology, etc. will be examined and statistically analyzed.If necessary, we will conduct interviews with patients. We take care to avoid compulsion on patients during interviews.

Management information
Registered date	2019 Year 11 Month 11 Day
Last modified on	2019 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043909